The present invention relates to a medical applicator assembly used as an aid in performing a radiological examination of a urinary bladder.
Many women experience occasional trivial degrees of urinary loss which needs no treatment. However, more frequent urinary incontinence during the stress of increased intra-abdominal pressure, such as occurs on sneezing or coughing, may be symptomatic of anatomic abnormalities that require treatment. Frequently, urinary incontinence is due to loss of the urethrovesical angle, that is, the angular relationship between the bladder and the urinary canal. Normally, the bladder slants obliquely downwardly and forwardly from the opening of the urinary canal forming an angular relationship therebetween which is approximately 90.degree.. Injury to the muscles and other ligaments which support the floor of the bladder or other conditions can result in a displacement of that angular relationship and an inability to control urine flow.
As mentioned, this urine control problem is only symptomatic of a bladder displacement condition and it is necessary for the physician to determine the existence and extent of any displacement in order to evaluate the need for surgical correction. Accordingly, prior to the initiation of any corrective surgical procedure of this type, it generally has been the practice to perform a cystourethrographic examination. In this procedure, a radiopaque liquid contrast media or dye and a metallic bead chain are used to study the angular relationship of the urinary canal to the bladder. During this procedure, a bead chain and contrast media are deposited within the bladder with the chain extending into the urinary canal. The chain conforms to the floor of the bladder so that when the X-ray or roentgenogram is taken, the physician is able to readily observe its contour along the floor of the bladder and through the urethra thereby also observing and determining the relative angular position between these members. Normally, if the angle is greater than 120.degree., a surgical procedure will be performed to correct the displacement and re-establish or restore the usual urethrovesical angle. After such surgical procedures, it is also conventional to perform a post-operative cystourethrogram to ensure that proper angular orientation has been achieved.
In accordance with prior art techniques, the cystourethrographic procedure involved the insertion of a catheter into the bladder so that the bladder could be drained immediately prior to injection of the radiopaque contrast solution. The catheter was then removed and one of two alternative procedures were followed. In accordance with one procedure, the removed catheter was split longitudinally along its entire length. The chain was then inserted into the split catheter and the catheter was reinserted through the urethra into the bladder in order to deposit the chain therein. In accordance with this technique, the catheter and the chain were disengaged after insertion and the catheter was removed or withdrawn leaving the chain in place in the urethra and the bladder. Unfortunately at times, the chain was not fully disengaged from the catheter resulting in at least partial extraction of the chain as the catheter was removed, thereby necessitating a repetition of the catheterization procedure. In accordance with the alternative technique, the chain was inserted by flexible forceps which manipulated the chain through the urethra in a link-by-link manner until the chain had been properly positioned within the bladder. The forcep method was often painful to the patient and required a physician of exceptionally high skill. A variation of the forcep procedure is disclosed in Nordstrom's U.S. Pat. No. 3,844,274. As will be appreciated, in both procedures, it was necessary to initially catheterize the patient to introduce the contrast media, remove the catheter and conduct a subsequent catheterization or forcep manipulation in order to properly locate the bead chain within the bladder.
A single catheterization procedure is described in Thaidigsman's U.S. Pat. No. 3,369,542 where a metal catheter was fixed to a housing block used for injecting the contrast liquid. A trailing wire of twice the length of the chain was secured to the chain and preloaded into the metal catheter through a radial opening spaced from the tip of the catheter. The present invention also avoids multiple catheterization, as well as the discomfort associated with the prior procedures, yet advantageously utilizes a substantially more simplified, economical and disposable construction well suited to easy, trouble-free and effective use.
Another feature of the present invention is the provision for a new and improved medical applicator assembly for use in a chain cystourethro examination of the type described which provides for a quicker, easier and relatively painless means of accurately depositing a metallic bead chain and contrast media within the bladder of the patient thereby rendering the patient more comfortable and reducing the length of time of the procedure.
Still another object of the present invention is to provide a medical applicator assembly of the type described that can be inexpensively produced as a highly flexible, disposable, sterilized assembly or as a partially disposable assembly thereby permitting not only a one time catheterization but at the same time avoiding the chance of inadvertent infection from reuse. Included in this object is the provision for disposability within those portions of the assembly which can be manufactured and replaced inexpensively.
Other objects will be in part obvious and in part pointed out more in detail hereinafter.
These and related objects are achieved in accordance with the present invention by providing a medical applicator assembly comprising a flexible intramedic tubing having a smooth uninterrupted outer surface and a hollow longitudinal passage extending axially along the entire length thereof with coaxial proximal and distal openings at opposite ends of the passage. A metallic bead chain of substantially the same length as the tubing is loosely and slideably positioned within the passage and is provided with a soft tip secured to the proximal end of the chain by embedding at least one bead of the chain therein. The tip is comprised of a stem portion that is slideably received within the proximal end opening of the passage and an integral head portion of larger diameter than the passage and of blunt tapered configuration, the tip extending axially beyond the proximal end of the tubing. The head portion of the tip forms a shoulder with the stem portion, which shoulder abuts the proximal end of the tubing and maintains the tip in assembled relationship with the tubing during the insertion of the tubing through the urinary canal and into the bladder of the patient. A flexible rod-like plunger of substantially smaller diameter than the passage is used to engage the distal end of the chain and slideably displace the chain relative to the tubing so as to dislodge the stem portion from the proximal opening of the tubing. The distal opening of the tubing is connectable to a reservoir of radiopaque high contrast fluid which can then be inserted into the bladder through the tubing prior to fully dislodging the chain and removing the tubing.
A better understanding of this invention will be obtained from the following detailed description and the accompanying drawing of an illustrative application of the invention.